NCT07369011

A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study. Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.

Conditions

• Sleep Apnea, Obstructive
• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	Eloralintide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2026-01-27
• Last updated: 2026-04-17

Locations

123 sites across 12 countries: United States, Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study